1. Field of the Invention
This invention relates to formulations which relieve hyperglycemia, control blood insulin, and obviate the consequential complications associated with diabetes mellitus and advanced aging, and describes methods for their use.
2. Description of the Related Art
Nonpregnant human adults with a fasting glucose concentration in venous plasma greater than 115 mg/dl are, by definition, hyperglycemic. (Neil B. Ruderman and Anthony McCall, Disorders of Carbohydrate Metabolism, pages 778-797, In Medicine, Eds. Robert W. Wilkins and Norman G. Levinsky, Little Brown and Company, Boston, 1983). Hyperglycemia is associated with diabetes mellitus, impaired glucose tolerance, and gestational diabetes. Persons with blood glucose concentrations greater than 115 but less than 140 mg/dl have impaired glucose tolerance (glucose intolerant). Persons with greater than 140 mg/dl blood glucose are regarded as diabetic.
Diabetes mellitus (DM) is defined as a group of disorders characterized by a relative or absolute lack of insulin and the presence of hyperglycemia. DM occurs in the following categories: type I or insulin-dependent DM; type II or noninsul-independent DM; nonobese DM; obese DM; maturity-onset diabetes of the young; and other types, including diabetes associated with certain conditions or syndromes.
The well-known acute and chronic complications of diabetes mellitus include diabetic ketoacidosis and hyperosmolar coma. In the absence of treatment, patients with DM die within 2 to 3 years of onset of the disease. The most important chronic complication of DM results from pathologic alteration in large and small blood vessels and in the nervous system. Such complications take the form of atherosclerosis, capillary angiopathy, and diabetic cardiopathy. Blindness, renal failure, gangrene, heart disease, peripheral neuropathy, and mononeuropathy may result. All of the above complications are likely a result of extensive glycosylation of proteins by the abnormally high concentration of glucose in blood and other tissues.
Some glucose intolerant persons develop type I or II DM. Glucose intolerance sometimes appears with pregnancy and is called gestational diabetes. Glucose intolerant persons have increased risk of atherosclerotic cardiovascular disease and greater risk of perinatal morbidity when pregnant. Patients with impaired glucose tolerance are often obese. Treatment is based on diet, exercise, and removal of drugs or other factors which may cause this condition.
Treatment of conditions involving hyperglycemia include diet. The diet for hyperglycemic persons is often comprised of 50% carbohydrate (primarily complex carbohydrates), not greater than 30% fat, and the remainder protein. Sugars such as sucrose and glucose are restricted because they elevate blood sugar levels. As a result, poor compliance with such diets is common. Sweeteners which do not elevate blood glucose levels are being sought for use in such diets to enhance compliance.
U.S. Pat. No. 4,786,722 discloses edible formulations and methods for preparation of edible formulations in which D-tagatose is used as a low-calorie carbohydrate sweetener and bulking agent. In this patent, D-tagatose was described as useful in foodstuffs and other edible formulations for people whose metabolizable carbohydrate intake must be restricted because of conditions such as diabetes mellitus or obesity.